Senior Clinical Research Associate

This is a fully remote position, open to applicants in United States.

📋 Description

• Assist in the implementation of clinical studies aimed at product development and validation.

• Establish robust relationships with clinical trial sites.

• Guarantee timely monitoring and audit preparedness at both the sponsor and site levels.

• Contribute to the creation of study reports and documents required for regulatory submissions.

• Collaborate effectively with colleagues and leadership across various departments.

• Maintain professional interactions with Investigators, site personnel, Institutional Review Boards, and key opinion leaders.

• Develop necessary study documentation.

• Conduct site selection and qualification processes.

• Provide training and support to sites regarding study procedures.

• Oversee study compliance and manage study closeout activities.

• Coordinate with monitors and data management teams to ensure data quality and timeliness.

• Contribute to ongoing process improvements within clinical study operations.

• Plan and execute site study operations with minimal oversight.

• Request and monitor supplies, documentation, and training materials.

• Generate progress reports for ongoing studies.

• Manage multiple studies simultaneously, aiming to decrease the time from the last participant to database lock while enhancing site compliance.

⛳️ Requirements

• Bachelor’s degree in a technical field with 5–8 years of relevant experience, or a Master’s degree with 2–5 years of equivalent industry experience, or a PhD with 0–2 years of experience.

• Demonstrated ability and judgment to operate under minimal supervision.

• Proven experience in planning and executing site study operations, including both on-site and remote training and support.

• Competence in requesting and tracking supplies and documentation.

• Capability to train sites and team members while generating progress reports.

• Strong communication skills with site staff, Principal Investigators, and internal study team members.

• Experience in cross-functional collaboration.

• Solid foundation in Good Clinical Practice (GCP) and clinical study knowledge.

• Previous experience as a Clinical Research Associate.

• Ability to manage multiple studies at once effectively.

• Experience working with monitors to minimize the duration from the last participant to database lock and enhance site compliance.

• Familiarity with electronic data capture systems (EDC), Clinical Trial Management Systems (CTMS), and electronic trial master files (eTMF).

• Preferred experience with Continuous Glucose Monitoring (CGM) Systems.

• Preferred background in diabetes clinical trials involving insulin therapies, insulin pumps, or digital health technologies.

• Willingness to travel 15–25% of the time.

🏝️ Benefits

• A comprehensive benefits package.

• Opportunities for growth on a global scale.

• Access to career development through in-house learning programs and/or qualified tuition reimbursement.

• Option for a home office workplace.

• Flex workplace options may be available.

• Commitment to being an Equal Opportunity Employer.

• Reasonable accommodations provided for individuals with disabilities.